Trial Testing the Effect of Strategies on Performance of Brief Intervention Programmes for Harmful Alcohol Consumption

Not Applicable

Completed

• Conditions: Alcoholism
• Interventions: Other: Training and support (T&S); Other: Financial incentive; Other: E-SBI (online screening and brief intervention)

• Registration Number: NCT01501552
• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

Brief Summary

The overall objective is to study if training and support, financial reimbursement and referral to an internet based brief intervention programme, singly or in combination, may increase implementation of evidence based methods of identification and brief intervention for excessive alcohol consumption in routine primary health care.

Detailed Description

The study will be a stepped cluster RCT in 5 countries and the endpoint of the study is the number of interventions delivered during a certain time period. More specifically, the RCT will examine:

* The effect of Continuous Medical Education (CME) to PHC providers

* The effect of financial reimbursement to PHC providers as a pay-for-performance of brief alcohol interventions

* Whether an alternative internet based method of delivering brief intervention can increase the proportion of patients reached

* If one implementation strategy will give an added value to one already enforced.

Study Timeline

• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-27
• Study First Posted: 2011-12-29
• Study Start: 2012-01
• Primary Completion: 2014-05
• Study Completion: 2014-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-05
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Primary Health Care Units (PHCU) of approximate size of 5.000-20.000 registered patients
• Primary Health Care Units (PHCU) located in Spain, Poland, Sweden, England or The Netherlands
• Providers must be physicians or nurses

Exclusion Criteria

• Primary Health Care Units with less than 5.000 registered patients or over 20.000 registered patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
T&S and financial incentive	Financial incentive	The T\&S and financial incentive group will be offered two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. Also, they will receive a financial incentive depending on their screening and brief intervention activities. They will be paid for the performance, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.
Financial incentive and e-SBI	E-SBI (online screening and brief intervention)	The financial incentive and e-SBI (online screening and brief intervention) group will be paid for screening and referral performance instead of actual delivery of e-SBI by themselves as in line with the e-SBI only group, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.
Financial incentive	Financial incentive	The financial incentive only group will receive a financial incentive depending on their screening and brief intervention activities. They will be paid for the performance, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.
E-SBI	E-SBI (online screening and brief intervention)	The e-SBI (online screening and brief intervention)only group are expected to refer identified at-risk patients to an approved e-SBI programme, which will be either country specific (where these exist) or based on the WHO e-SBI programme (Poland).
T&S and e-SBI	E-SBI (online screening and brief intervention)	The T\&S and e-SBI group will be offered two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. The telephone call was offered to one of the GPs ('leader'). Depending on the needs of the PHCU, one additional face to face training (1 to 2 hours) was offered. Also this group is expected to refer identified at-risk patients to an approved e-SBI (online screening and brief intervention) programme, which will either be country specific (where these exist) or based on the WHO e-SBI programme (Poland).
Financial incentive and e-SBI	Financial incentive	The financial incentive and e-SBI (online screening and brief intervention) group will be paid for screening and referral performance instead of actual delivery of e-SBI by themselves as in line with the e-SBI only group, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.
T&S and financial incentive	Training and support (T&S)	The T\&S and financial incentive group will be offered two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. Also, they will receive a financial incentive depending on their screening and brief intervention activities. They will be paid for the performance, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.
T&S and e-SBI	Training and support (T&S)	The T\&S and e-SBI group will be offered two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. The telephone call was offered to one of the GPs ('leader'). Depending on the needs of the PHCU, one additional face to face training (1 to 2 hours) was offered. Also this group is expected to refer identified at-risk patients to an approved e-SBI (online screening and brief intervention) programme, which will either be country specific (where these exist) or based on the WHO e-SBI programme (Poland).
T&S, financial incentive and e-SBI	Training and support (T&S)	The T\&S, financial incentive and e-SBI (online screening and brief intervention) group will be offered two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. The telephone call will be offered to one of the GPs ('leader'). Also, they are expected to offer screening at the PHCU and to refer screen positive patients to e-SBI programmes. Additionally, they will be paid for screening and referral performance, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.
T&S, financial incentive and e-SBI	Financial incentive	The T\&S, financial incentive and e-SBI (online screening and brief intervention) group will be offered two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. The telephone call will be offered to one of the GPs ('leader'). Also, they are expected to offer screening at the PHCU and to refer screen positive patients to e-SBI programmes. Additionally, they will be paid for screening and referral performance, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.
Training & support (T&S)	Training and support (T&S)	The T\&S only group will be offered two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. The telephone call will be offered to one of the GPs ('leader'). Depending on the needs of the PHCU, one additional face to face training (1 to 2 hours) may be offered. The time interval between meetings will be on average 2 weeks. The training sessions will address improving knowledge, skills, attitudes, and perceived barriers and facilitators by combining theory and practice-based training.
T&S, financial incentive and e-SBI	E-SBI (online screening and brief intervention)	The T\&S, financial incentive and e-SBI (online screening and brief intervention) group will be offered two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. The telephone call will be offered to one of the GPs ('leader'). Also, they are expected to offer screening at the PHCU and to refer screen positive patients to e-SBI programmes. Additionally, they will be paid for screening and referral performance, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.

Primary Outcome Measures

Name	Time	Method
Number of brief interventions for excessive alcohol consumption delivered in primary health care settings	5 months	Brief intervention rates will be calculated at five time points: during a four week period during the third month before the start of the study (baseline measurement), in three consecutive four week blocks during the twelve week intervention period (intervention measurement) and during a four week block during the sixth month after the end of the intervention period (follow-up measurement).
Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care	5 months	Screening rates will be calculated at five time points: during a four week period during the third month before the start of the study (baseline measurement), in three consecutive four week blocks during the twelve week intervention period (intervention measurement) and during a four week block during the sixth month after the end of the intervention period (follow-up measurement).

Secondary Outcome Measures

Name	Time	Method
Level of role security of primary health care providers measured by their answers to the SAAPPQ instrument	3 months	Role security of the primary health care providers will be measured through their responses to the SAAPPQ (a validated instrument based on factor analysis (Anderson \& Clement 1987) of the original alcohol and alcohol problems perception questionnaire developed and validated by Cartwright (1980))at three time points: baseline, end of intervention period, and follow-up.
Level of therapeutic commitment of primary health care providers measured by their answers to the SAAPPQ instrument	3 months	Therapeutic commitment of the primary health care providers will be measured through their responses to the SAAPPQ (a validated instrument based on factor analysis (Anderson \& Clement 1987) of the original alcohol and alcohol problems perception questionnaire developed and validated by Cartwright (1980))at three time points: baseline, end of intervention period, and follow-up.

Trial Locations

Locations (10)

Pomorski Uniwersytet Medyczny w Szczecinie; 🇵🇱 Szczecin, Poland

Linköping University; 🇸🇪 Linköping, Sweden

Panstwowa Agencja Rozwiazywania Problemow Alkoholowych; 🇵🇱 Warsaw, Poland

Goeteborgs Universitet; 🇸🇪 Goeteborg, Sweden

Maastricht University; 🇳🇱 Maastricht, Netherlands

Stichting Katholieke Universiteit; 🇳🇱 Nijmegen, Netherlands

Departament de Salut de la Generalitat de Catalunya; 🇪🇸 Barcelona, Catalonia, Spain

University College, London; 🇬🇧 London, England, United Kingdom

University of Newcastle Upon-Tyne; 🇬🇧 Newcastle Upon-Tyne, England, United Kingdom

King's College London; 🇬🇧 London, England, United Kingdom